Knee ArthropathyNCT05170321
Analysis of Influencing Factors and Construction of Prediction Models of Artificial Joint Replacement in China
An observational study of Knee Arthropathy and Hip Arthropathy, run by Xiangya Hospital of Central South University at 1 site in China.
Trial summary
The project intends to analyze the epidemiological characteristics, risk factors, complications and resource utilization of artificial joint replacement in China through the inpatient data collected by the Hospital Quality Monitoring System (HQMS). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Knee Arthropathy, Hip Arthropathy, Shoulder Arthropathy
- How many people
- 600,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 1 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who underwent knee, hip, shoulder, ankle and elbow arthroplasty were included.
Who may be able to join
- Patients who underwent knee, hip, shoulder, ankle and elbow arthroplasty in HQMS
Who cannot join
- Patients who didn't undergo knee, hip, shoulder, ankle and elbow arthroplasty
- Patients with missing demographics or medical data
Trial locations and contacts
1 site in 1 country.
China1 site
Xiangya Hospital of Central South University
Changsha, Hunan, 410008
About this study
The project intends to analyze the epidemiological characteristics, risk factors, complications and resource utilization of artificial joint replacement in China through the inpatient data collected by the Hospital Quality Monitoring System (HQMS). The HQMS database is a mandatory electronic inpatient database system developed by the National Health Commission of the People's Republic of China. Since 2013, tertiary hospitals have been required to upload their inpatient discharge records. By 2019, the HQMS database has included more than 230 million standardized inpatient discharge records of over 1000 hospitals across all 31 provincial-level administrative regions in mainland China. Patient demographics, clinical diagnosis, procedures and operations, drug use, costs and complications were all recorded in the HQMS database. The investigators planned to include five types of arthroplasty, including knee arthroplasty, hip arthroplasty, shoulder arthroplasty, ankle arthroplasty and elbow arthroplasty. The data analysis will be conformed to the principle of confidentiality and will not reveal the privacy of those patients. The data will be only used for this research project and there is no conflict of interest. It is in line with the principles of ethics, harmlessness and fairness. This study was authorized by the HQMS Committee Board and approved by the institutional review board, with waiver of informed consent.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients undergoing knee arthroplasty in Hospital Quality Monitoring System in China | Patients who underwent knee arthroplasty and was recorded in HQMS were included in this group | |
| patients undergoing hip arthroplasty in Hospital Quality Monitoring System in China | Patients who underwent hip arthroplasty and was recorded in HQMS were included in this group | |
| patients undergoing shoulder arthroplasty in Hospital Quality Monitoring System in China | Patients who underwent shoulder arthroplasty and was recorded in HQMS were included in this group | |
| patients undergoing ankle arthroplasty in Hospital Quality Monitoring System in China | Patients who underwent ankle arthroplasty and was recorded in HQMS were included in this group | |
| patients undergoing elbow arthroplasty in Hospital Quality Monitoring System in China | Patients who underwent elbow arthroplasty and was recorded in HQMS were included in this group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epidemiological characteristics, complications, risk factors and resource utilization of knee arthroplasty in China
The project intends to analyze the epidemiological characteristics, complications, risk factors and resource utilization of artificial knee joint replacement in China through the inpatient data collected by the Hospital Quality Monitoring System (HQMS). The information collected by HQMS includes demographics characteristics, hospitalization information, medical care cost, complications, et al.
Measured: 10 years (2013-2022)
Epidemiological characteristics, complications, risk factors and resource utilization of hip arthroplasty in China
The project intends to analyze the epidemiological characteristics, complications, risk factors and resource utilization of artificial hip joint replacement in China through the inpatient data collected by the Hospital Quality Monitoring System (HQMS). The information collected by HQMS includes demographics characteristics, hospitalization information, medical care cost, complications, et al.
Measured: 10 years (2013-2022)
Epidemiological characteristics, complications, risk factors and resource utilization of shoulder arthroplasty in China
The project intends to analyze the epidemiological characteristics, complications, risk factors and resource utilization of artificial shoulder joint replacement in China through the inpatient data collected by the Hospital Quality Monitoring System (HQMS). The information collected by HQMS includes demographics characteristics, hospitalization information, medical care cost, complications, et al.
Measured: 10 years (2013-2022)
Epidemiological characteristics, complications, risk factors and resource utilization of ankle arthroplasty in China
The project intends to analyze the epidemiological characteristics, complications, risk factors and resource utilization of artificial ankle joint replacement in China through the inpatient data collected by the Hospital Quality Monitoring System (HQMS). The information collected by HQMS includes demographics characteristics, hospitalization information, medical care cost, complications, et al.
Measured: 10 years (2013-2022)
Epidemiological characteristics, complications, risk factors and resource utilization of elbow arthroplasty in China
The project intends to analyze the epidemiological characteristics, complications, risk factors and resource utilization of artificial elbow joint replacement in China through the inpatient data collected by the Hospital Quality Monitoring System (HQMS). The information collected by HQMS includes demographics characteristics, hospitalization information, medical care cost, complications, et al.
Measured: 10 years (2013-2022)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2021
- Study start1 Jan 2018
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Knee ArthropathyStudies of the same condition, open and under way.
- More trials run by Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 600,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guanghua Lei, PhD; MD, Principal investigator, Xiangya Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05170321
- Sponsor's protocol ID
- 2017121016
- Status last verified
- Nov 2021
- First submitted
- 8 Dec 2021
- Last updated
- 14 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators do not wish to share our data according to the policy of our hospital, the data could not be shared with others without permission.
Publications
Zeng C, Lane NE, Englund M, Xie D, Chen H, Zhang Y, Wang H, Lei G. In-hospital mortality after hip arthroplasty in China: analysis of a large national database. Bone Joint J. 2019 Oct;101-B(10):1209-1217. doi: 10.1302/0301-620X.101B10.BJJ-2018-1608.R1.
PubMed 31564156Wang Y, Jiang Q, Long H, Chen H, Wei J, Li X, Wang H, Xie D, Zeng C, Lei G. Trends and benefits of early hip arthroplasty for femoral neck fracture in China: a national cohort study. Int J Surg. 2024 Mar 1;110(3):1347-1355. doi: 10.1097/JS9.0000000000000794.
PubMed 38320106Long H, Xie D, Chen H, Wei J, Li X, Wang H, Zeng C, Lei G. Rural-urban differences in characteristics, postoperative outcomes, and costs for patients undergoing knee arthroplasty: a national retrospective propensity score matched cohort study. Int J Surg. 2023 Sep 1;109(9):2696-2703. doi: 10.1097/JS9.0000000000000494.
PubMed 37247007
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Influencing Factors and Construction of Prediction Models of Artificial Joint Replacement in China
- ClinicalTrials.gov ID
- NCT05170321
- Acronym / sponsor ID
- 2017121016
- Conditions
- Knee Arthropathy, Hip Arthropathy, Shoulder Arthropathy, Ankle Arthropathy, Elbow Arthropathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600,000 participants (estimated)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 27 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The project intends to analyze the epidemiological characteristics, risk factors, complications and resource utilization of artificial joint replacement in China through the inpatient data collected by the Hospital Quality Monitoring System (HQMS). The HQMS database is a mandatory electronic inpatient database system developed by the National Health Commission of the People's Republic of China. Since 2013, tertiary hospitals have been required to upload their inpatient discharge records. By 2019, the HQMS database has included more than 230 million standardized inpatient discharge records of over 1000 hospitals across all 31 provincial-level administrative regions in mainland China. Patient demographics, clinical diagnosis, procedures and operations, drug use, costs and complications were all recorded in the HQMS database. The investigators planned to include five types of arthroplasty, including knee arthroplasty, hip arthroplasty, shoulder arthroplasty, ankle arthroplasty and elbow arthroplasty. The data analysis will be conformed to the principle of confidentiality and will not reveal the privacy of those patients. The data will be only used for this research project and there is no conflict of interest. It is in line with the principles of ethics, harmlessness and fairness. This study was authorized by the HQMS Committee Board and approved by the institutional review board, with waiver of informed consent.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| patients undergoing knee arthroplasty in Hospital Quality Monitoring System in China | – | –Patients who underwent knee arthroplasty and was recorded in HQMS were included in this group |
| patients undergoing hip arthroplasty in Hospital Quality Monitoring System in China | – | –Patients who underwent hip arthroplasty and was recorded in HQMS were included in this group |
| patients undergoing shoulder arthroplasty in Hospital Quality Monitoring System in China | – | –Patients who underwent shoulder arthroplasty and was recorded in HQMS were included in this group |
| patients undergoing ankle arthroplasty in Hospital Quality Monitoring System in China | – | –Patients who underwent ankle arthroplasty and was recorded in HQMS were included in this group |
| patients undergoing elbow arthroplasty in Hospital Quality Monitoring System in China | – | –Patients who underwent elbow arthroplasty and was recorded in HQMS were included in this group |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who underwent knee, hip, shoulder, ankle and elbow arthroplasty were included.
Key inclusion criteria (1 listed)
- Patients who underwent knee, hip, shoulder, ankle and elbow arthroplasty in HQMS
Key exclusion criteria (2 listed)
- Patients who didn't undergo knee, hip, shoulder, ankle and elbow arthroplasty
- Patients with missing demographics or medical data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Epidemiological characteristics, complications, risk factors and resource utilization of knee arthroplasty in China
Time frame: 10 years (2013-2022)
The project intends to analyze the epidemiological characteristics, complications, risk factors and resource utilization of artificial knee joint replacement in China through the inpatient data collected by the Hospital Quality Monitoring System (HQMS). The information collected by HQMS includes demographics characteristics, hospitalization information, medical care cost, complications, et al.
Epidemiological characteristics, complications, risk factors and resource utilization of hip arthroplasty in China
Time frame: 10 years (2013-2022)
The project intends to analyze the epidemiological characteristics, complications, risk factors and resource utilization of artificial hip joint replacement in China through the inpatient data collected by the Hospital Quality Monitoring System (HQMS). The information collected by HQMS includes demographics characteristics, hospitalization information, medical care cost, complications, et al.
Epidemiological characteristics, complications, risk factors and resource utilization of shoulder arthroplasty in China
Time frame: 10 years (2013-2022)
The project intends to analyze the epidemiological characteristics, complications, risk factors and resource utilization of artificial shoulder joint replacement in China through the inpatient data collected by the Hospital Quality Monitoring System (HQMS). The information collected by HQMS includes demographics characteristics, hospitalization information, medical care cost, complications, et al.
Epidemiological characteristics, complications, risk factors and resource utilization of ankle arthroplasty in China
Time frame: 10 years (2013-2022)
The project intends to analyze the epidemiological characteristics, complications, risk factors and resource utilization of artificial ankle joint replacement in China through the inpatient data collected by the Hospital Quality Monitoring System (HQMS). The information collected by HQMS includes demographics characteristics, hospitalization information, medical care cost, complications, et al.
Epidemiological characteristics, complications, risk factors and resource utilization of elbow arthroplasty in China
Time frame: 10 years (2013-2022)
The project intends to analyze the epidemiological characteristics, complications, risk factors and resource utilization of artificial elbow joint replacement in China through the inpatient data collected by the Hospital Quality Monitoring System (HQMS). The information collected by HQMS includes demographics characteristics, hospitalization information, medical care cost, complications, et al.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2022.
- Background: PubMed 31564156Zeng C, Lane NE, Englund M, Xie D, Chen H, Zhang Y, Wang H, Lei G. In-hospital mortality after hip arthroplasty in China: analysis of a large national database. Bone Joint J. 2019 Oct;101-B(10):1209-1217. doi: 10.1302/0301-620X.101B10.BJJ-2018-1608.R1.
- Derived from this study: PubMed 38320106Wang Y, Jiang Q, Long H, Chen H, Wei J, Li X, Wang H, Xie D, Zeng C, Lei G. Trends and benefits of early hip arthroplasty for femoral neck fracture in China: a national cohort study. Int J Surg. 2024 Mar 1;110(3):1347-1355. doi: 10.1097/JS9.0000000000000794.
- Derived from this study: PubMed 37247007Long H, Xie D, Chen H, Wei J, Li X, Wang H, Zeng C, Lei G. Rural-urban differences in characteristics, postoperative outcomes, and costs for patients undergoing knee arthroplasty: a national retrospective propensity score matched cohort study. Int J Surg. 2023 Sep 1;109(9):2696-2703. doi: 10.1097/JS9.0000000000000494.
- Individual participant dataSharing planned: No. The investigators do not wish to share our data according to the policy of our hospital, the data could not be shared with others without permission.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guanghua Lei, PhD; MD principal investigator
Xiangya Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Arthropathy and Hip Arthropathy, run by Xiangya Hospital of Central South University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epidemiological characteristics, complications, risk factors and resource utilization of knee arthroplasty in China (time frame: 10 years (2013-2022)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05170321, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2022; AzTrials last refreshed its copy on 8 Nov 2026.